# K150185: Mont Blanc Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spineway
- Decided: May 12, 2015 after 105 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K901587 (1990). 22 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112684: Mont Blanc Pedicle Screw Systems, Qualgenix (2012) Summary page 4.

## Most influential descendants
- K161387: Mont Blanc and Mont Blanc MIS Spinal Systems (2016), 3 descendants of its own
- K253045: “Socko” Vimax Spinal Fixation System (2026), 0 descendants of its own
- K231658: VEOS Spinal Fixation System (2023), 0 descendants of its own
- K191726: mont blanc & mont blanc MIS Spinal Systems (2019), 0 descendants of its own

## Indications for use
The Mont Blanc Spinal System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae and sacral/iliac screw fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K150185
Methodology: https://510kreport.com/methodology